FDA warns Ontario clinic for selling products claiming to 'treat or prevent' coronavirus

A holistic medicine clinic in Sarnia, Ont. has received a warning letter by the U.S. Food and Drug Administration for selling products that are "intended to mitigate, prevent, treat, diagnose or cure COVID-19 in people."

The FDA reviewed the website, coronavirusdefense.com — operated by Vivify Holistic Clinic — and determined that it offered "unapproved" and "misbranded" drugs which violates the U.S. Federal Food, Drug, and Cosmetic Act.

"We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19," the FDA added in its warning letter issued Friday.

Six other businesses in the U.S. were issued warning letters as well.

In its letter to Vivify, the FDA pointed to five examples of "misleadingly" representing products as effective in the treatment or prevention of COVID-19:

• A Jan. 27 post on Vivify's Facebook page directed customers to coronavirusdefense.com, which promotes the "protocols" of herbal medicine advocate Stephen Buhner. The post ends by saying its author has been "working very hard to set up a website coronavirusdefense.com up to sell Mr. Buhner's protocol."
• Another Facebook post on Jan. 27 suggests drinking "boneset tea" six times a day, with the author saying it works well against "other corona virus infections, including SARS."
• An excerpt from coronavirusdefense.com states Stephen Buhner has created an "updated coronavirus protocol specifically for the Wuhan outbreak."
• An excerpt from coronavirusdefense.com describes a formula for "boneset" loose leaf tea, suggesting customers drink one cup six times a day for an acute dosage or two cups four times a day for a chronic dosage.
• An excerpt from coronavirusdefense.com states "each 100 ml of product" will last 16 days for a "preventative dose" and eight days for an "infection dosage." The post suggests consuming three extracts as a preventative dose — and four products for people who are already infected.

According to the U.S. FDA, there currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products available to treat or cure COVID-19.

"It is unlawful ... to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made," the FDA said.

"To make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act."

In an email statement, a Vivify spokesperson said the company "supports the FDA and FTC's mandate to protect the public."

"Their letter had referenced several excerpts of a quote on the website and social media accounts which cited a well-known author and herbalist who created the protocol based on his research and previous experience,"  wrote David Raes. "These quotes were unfortunately misattributed to Vivify by several in the media. Vivify has removed his quote and all reference to the virus, and instead suggest people read his material if interested in the topic."

Raes added that "there were no medical claims on the bottles."

A Health Canada spokesperson wrote to CBC News explaining that the department "has not approved any product to treat or cure COVID-19."

"Health Canada is aware that the US Food and Drug Administration (US FDA) has issued warning letters to seven companies for falsely selling or advertising products claiming to cure, treat or prevent COVID-19," wrote Tammy Jarbeau, senior media relations advisor with Health Canada. "The Department is actively following up on two companies – Vivify Holistic Clinic and The Jim Bakker Show and assessing the other cases referenced by the US FDA as a priority to determine whether the same product is sold in Canada."

"It's frustrating," said Lori Lucas, Lambton Public Health's supervisor of health protection. "I think it's just a little bit concerning that we have somebody locally trying to take advantage of the situation."

She said there's been a ton of misinformation regarding COVID-19 spreading on social media, adding it's important for people to refer to "credible sources" when seeking medical information.

"At this point in time, there is no vaccine and there are no treatments out there," said Lucas when asked if there are any supplements or tea extracts that are effective in fighting coronavirus.

The violations cited in the warning letter, which the FDA clarifies is "not meant to be all-inclusive list," appear to have been corrected.

Vivify Holistic Clinic has been added to a published list of "firms and websites" that have received warning letters from the FDA for selling and distributing fraudulent COVID-19 products.

Lambton Public Health said the "level of risk" for a coronavirus outbreak in the region is low, as health officials continue to closely monitor the situation.